DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of US Application no. 17/885,799, now US Patent no. 12,179,023, filed 11 August 2022, which is a continuation of US Application no. 16/587,527, now US Patent no. 11,420,057, filed 30 September 2019, which is a continuation of US Application no. 15/888,338, now US Patent no. 10,426,959, filed 5 February 2018, which is a continuation of US Application no. 15/132,932, now US Patent no. 9,884,189, filed 19 April 2016, which is a continuation of US Application no. 14/522,918, now abandoned, filed 5 February 2018, which is a continuation-in-part of US Application nos. 12/653,029, now abandoned, filed 7 December 2009 and 12/653,023, now US Patent no. 8,954,153, filed 7 December 2009, which claims the benefit of domestic priority from US Provisional Application no. 61/201,030, filed 5 December 2008.
Response to Amendment
The preliminary amendment filed 4 June 2025 has been acknowledged. Claims 1-32 are pending, wherein claims 21-32 are new.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 10, 21-23, and 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rooney et al. (US Publication no. 2007/0150034) in view of Strother et al. (US Publication no. 2007/0060980), further in view of Libbus et al. (US Patent no. 8,103,341 – disclosed by Applicant).
In regard to claim 1, Rooney et al. disclose a method comprising:
inserting an electrode into a tissue until the electrode is in an operative electrical position relative to a peripheral nerve innervating a painful region (para 8 and 21, for treatment of pain with peripheral nerve stimulation, the electrodes are implanted in close proximity upstream from the source or pain; the proximal location of Rooney et al. comprising an “operative electrical position relative” to the nerve);
applying electrical stimulation to the peripheral nerve through the electrode and an electrical stimulation device (para 61, i.e., delivery of stimulation);
activating the peripheral nerve through the application of the electrical stimulation to the peripheral nerve (para 61-64, via the applied stimulation); and
evoking paresthesia over at least a portion of the painful region without damaging the peripheral nerve (para 62, stimulation from electrodes located upstream of the pain region provides paresthesia to the region where the patient perceives pain).
Rooney et al. does not teach using a single contact electrode placed in operative electrical position relative to a peripheral nerve. Strother et al. discloses implantable pulse generator systems and teaches that monopolar electrode configurations are known and are preferred in situations where the electrode may be located further from the target tissue region (para 309) which is beneficial since activation of the tissue is less sensitive to exact placement of the electrode. This is considered useful in Rooney et al. which places the electrode proximate or near the target peripheral nerve is a region upstream of the painful region so that the target nerve can achieve effective neural activation with a lower stimulation threshold. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the peripheral nerve stimulation teaching of Rooney et al. to use a single contact or monopolar electrode since Strother et al. explicitly teach that monopolar electrodes offer the advantage that activation of the tissue is less sensitive to less exact electrode placement, thereby reducing the need for precise electrode placement which in turn would simplify implantation, improve procedural flexibility, reduce implant time, and lower energy use.
Additionally, the technique described above allowing for the electrode to be placed away from the target nerve is considered to prevent damage to the nerve. However, neither reference expressly teaches the limitation. Libbus et al. teach that during nerve stimulation (such as that applied by Rooney et al.), various side effects may occur. For instance, the stimulated nerve may be damaged over time due to a charge build-up from delivered electrical stimulation energy (col 3 line 59 - col 4 line 5). To alleviate this side effect, Libbus et al. apply a charge balanced biphasic waveform. This type of waveform prevents the build-up of charge left on the tissue that may cause damage, while also providing the intended therapeutic effect. Thus Libbus et al. teach and suggest that electrical stimulation therapy can be applied without causing damage to the nerve. Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the treatment system and method of Rooney et al. to apply the stimulation using charge-balanced biphasic waveforms since Libbus et al. explicitly teach that said waveforms prevent tissue damage commonly associated with electrical stimulation therapy that may create further conduction abnormalities.
In regard to claim 2, Strother et al. teach that the single contact electrode comprises a surface area of 0.001-200 mm² (para 311, 10-20 mm² which anticipates the claimed range).
In regard to claim 3, Strother et al. teach that the single contact electrode comprises a surface area of 0.01-40 mm² (para 311, 10-20 mm² which anticipates the claimed range).
In regard to claim 4, Strother et al. teach that the single contact electrode comprises a surface area of 20 mm² (para 311, 20 mm² which anticipates the claimed value).
In regard to claim 10, Strother et al. teach that the single contact electrode is monopolar (para 308-315, monopolar configuration using electrode 16 and device housing).
In regard to claim 21, Rooney et al. teach that the monopolar single contact electrode comprises an anchoring element sized and configured so that, when in contact with the tissue, the anchoring element takes purchase in the tissue and resists dislodgement or migration out of the tissue (para 160-162, includes barbs or tines).
In regard to claim 22, Rooney et al. teach the lead comprises one anchoring element located at a distal region of the lead (para 163).
In regard to claim 23, Rooney et al. teach the lead comprises more than one anchoring element located at a distal region of the lead (para 162).
In regard to claim 30, Strother et al. teaches the monopolar lead configuration (para 78). Additionally, Strother et al. are considered to show the monopolar electrode lead is electrically insulated everywhere except at two conduction locations, wherein the conduction locations are connected to conductors that run a length of the monopolar electrode lead, providing electrical continuity from the conduction location through the monopolar electrode lead to the electrical stimulation device (the lead of Strother et al. includes at least two conduction locations shown as electrodes 16 in figure 33 located at the distal tip of the lead, wherein the electrodes are connected to conductors such as coil stranded segment 154 running the length of the lead, the wires provide electrical continuity along the length of the lead from the standard IS-1 connector located at the proximal end of the lead to the electrodes 16, para 304-306).
Claims 5-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rooney et al. (US Publication no. 2007/0150034) in view of Strother et al. (US Publication no. 2007/0060980) and Libbus et al. (US Patent no. 8,103,341 – disclosed by Applicant), further in view of Gerber (US Publication no. 2008/0183236) and Kuzma et al. (US Publication no. 2009/0024196).
In regard to claims 5-9, Rooney et al. in view of the cited prior art suggest the invention as claimed however none of the references teach the shape of the electrode being cylindrical, conical, spherical, hemispherical, circular, triangular, trapezoidal, raised, depressed, or flat. Gerber et al. describes a lead in which the electrodes are cylindrical and extend around the circumference body of the lead (para 97). Additionally, Gerber et al. teach that the electrodes may be ring electrodes, coiled, or formed from spherically shaped member (para 100). Kuzma et al. teaches that electrodes may be ring electrodes, coiled, or formed from spherically shaped member (para 100). Kuzma et al. describes an implantable lead with a conical electrode (claim 1). In view of the claims’ alternative recitation of various shapes the electrode may take suggests that the shape is matter of choice in design dependent on intended current-density distribution to be generated, and that each shape would perform equally well to other shapes for the intended purposes. Thus, there is no criticality to the particular shape selected. Therefore, it is considered to have been obvious to one of ordinary skill in the art to select an electrode shape from known shapes suitable for generating the desired electrical field as a matter of routine choice in engineering design according to manufacturing considerations, electrical contact characteristics, implantation techniques, and current-density distribution.
Claims 11-13, 15, 16, 19, 20, 25-27, 29, 31, and 32 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rooney et al. (US Publication no. 2007/0150034) in view of Strother et al. (US Publication no. 2007/0060980), further in view of Massengale (US Publication no. 2008/0300530) and Libbus et al. (US Patent no. 8,103,341 – disclosed by Applicant).
In regard to claim 11, Rooney et al. disclose a method comprising:
inserting an electrode into a tissue until the electrode is in operative electrical position relative to a peripheral nerve innervating a painful region (para 8 and 21, for treatment of pain with peripheral nerve stimulation, the electrodes are implanted in close proximity upstream from the source or pain; the proximal location of Rooney et al. comprising an “operative electrical position relative” to the nerve);
applying electrical stimulation to the peripheral nerve through the electrode and an electrical stimulation device (para 61-64, via the applied stimulation);
activating the peripheral nerve through the application of the electrical stimulation to the peripheral nerve (para 62, stimulation from electrodes located upstream of the pain region provides paresthesia to the region where the patient perceives pain).
Rooney et al. does not teach using a single contact electrode placed in operative electrical position relative to a peripheral nerve. Strother et al. discloses implantable pulse generator systems and teaches that monopolar electrode configurations are known and are preferred in situations where the electrode may be located further from the target tissue region (para 309) which is beneficial since activation of the tissue is less sensitive to exact placement of the electrode. This is considered useful in Rooney et al. which places the electrode proximate or near the target peripheral nerve is a region upstream of the painful region so that the target nerve can achieve effective neural activation with a lower stimulation threshold. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the peripheral nerve stimulation teaching of Rooney et al. to use a single contact or monopolar electrode since Strother et al. explicitly teach that monopolar electrodes offer the advantage that activation of the tissue is less sensitive to less exact electrode placement, thereby reducing the need for precise electrode placement which in turn would simplify implantation, improve procedural flexibility, reduce implant time, and lower energy use.
Neither Rooney et al. nor Strother et al. teach evoking muscle contraction within at least a portion of the targeted painful region nor for providing the stimulation without damaging the peripheral nerve.
Massengale teaches that in order to determine proximity of a stimulation device to a peripheral nerve, an electrical stimulation signal is transmitted to the target nerve to cause a contraction or twitch in the muscle innervated by that nerve (para 109). The magnitude of the twitch is dependent on the applied voltage and proximity of the stimulation tip to the nerve. Modification of Rooney et al. to apply the electrical stimulation to a peripheral nerve to evoke a twitch or contraction in the muscle is considered to have been obvious to one of ordinary skill in the art since Massengale explicitly teaches that motor responses are commonly used during implantation to verify appropriate electrode placement before chronic stimulation. The modification would comprise the application of a known technique of using a visible muscle twitch to aid in adjusting placement of a stimulation electrode.
Additionally, the technique described above allowing for the electrode to be placed away from the target nerve is considered to prevent damage to the nerve. However, no reference expressly teaches the limitation. Libbus et al. teach that during nerve stimulation (such as that applied by Rooney et al.), various side effects may occur. For instance, the stimulated nerve may be damaged over time due to a charge build-up from delivered electrical stimulation energy (col 3 line 59 - col 4 line 5). To alleviate this side effect, Libbus et al. apply a charge balanced biphasic waveform. This type of waveform prevents the build-up of charge left on the tissue that may cause damage, while also providing the intended therapeutic effect. Thus Libbus et al. teach and suggest that electrical stimulation therapy can be applied without causing damage to the nerve. Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the treatment system and method of Rooney et al. to apply the stimulation using charge-balanced biphasic waveforms since Libbus et al. explicitly teach that said waveforms prevent tissue damage commonly associated with electrical stimulation therapy that may create further conduction abnormalities.
In regard to claim 12, Rooney et al. teach that the monopolar single contact electrode comprises an anchoring element sized and configured so that, when in contact with the tissue, the anchoring element takes purchase in the tissue and resists dislodgement or migration out of the tissue (para 160-162, includes barbs or tines).
In regard to claim 13, Rooney et al. teach a fixation mechanism to prevent the lead from migration, wherein during insertion the fixation mechanism may be in a collapsed state that when expelled from the insertion device expand to preventing withdrawal of lead from the tissue. This is considered to be suggestive of the anchoring element sized and configured so that, when in contact with the tissue, the anchoring element takes purchase in the tissue and resists dislodgement or migration out of the tissue. Moreover, Strother et al. including a anchoring mechanism for similar reasons, and explicitly teaches that the electrode is not deployed until after it has been correctly located during the implantation (installation) process (para 316, also para 314-318).
In regard to claim 15, Rooney et al. disclose a method comprising:
inserting an electrode into a tissue until the electrode is in operative electrical position relative to a peripheral nerve innervating a painful region and wherein the single contact electrode comprises an anchoring element (para 8 and 21, for treatment of pain with peripheral nerve stimulation, the electrodes are implanted in close proximity upstream from the source or pain; the proximal location of Rooney et al. comprising an “operative electrical position relative” to the nerve);
applying electrical stimulation to the peripheral nerve through electrode and an electrical stimulation device, wherein the electrical stimulation comprises an intensity (para 61-64, via the applied stimulation; para 7 and 71, stimulation for PNS is applied with a signal amplitude which is considered the same as the intensity);
activating the peripheral nerve through the application of the electrical stimulation to the peripheral nerve (para 62, stimulation from electrodes located upstream of the pain region provides paresthesia to the region where the patient perceives pain).
Rooney et al. does not teach using a single contact electrode placed in operative electrical position relative to a peripheral nerve. Strother et al. discloses implantable pulse generator systems and teaches that monopolar electrode configurations are known and are preferred in situations where the electrode may be located further from the target tissue region (para 309) which is beneficial since activation of the tissue is less sensitive to exact placement of the electrode. This is considered useful in Rooney et al. which places the electrode proximate or near the target peripheral nerve is a region upstream of the painful region so that the target nerve can achieve effective neural activation with a lower stimulation threshold. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the peripheral nerve stimulation teaching of Rooney et al. to use a single contact or monopolar electrode since Strother et al. explicitly teach that monopolar electrodes offer the advantage that activation of the tissue is less sensitive to less exact electrode placement, thereby reducing the need for precise electrode placement which in turn would simplify implantation, improve procedural flexibility, reduce implant time, and lower energy use.
Neither Rooney et al. nor Strother et al. teach evoking muscle contraction within at least a portion of the targeted painful region nor for providing the stimulation without damaging the peripheral nerve.
Massengale teaches that in order to determine proximity of a stimulation device to a peripheral nerve, an electrical stimulation signal is transmitted to the target nerve to cause a contraction or twitch in the muscle innervated by that nerve (para 109). The magnitude of the twitch is dependent on the applied voltage and proximity of the stimulation tip to the nerve. Modification of Rooney et al. to apply the electrical stimulation to a peripheral nerve to evoke a twitch or contraction in the muscle is considered to have been obvious to one of ordinary skill in the art since Massengale explicitly teaches that motor responses are commonly used during implantation to verify appropriate electrode placement before chronic stimulation. The modification would comprise the application of a known technique of using a visible muscle twitch to aid in adjusting placement of a stimulation electrode.
Additionally, the technique described above allowing for the electrode to be placed away from the target nerve is considered to prevent damage to the nerve. However, no reference expressly teaches the limitation. Libbus et al. teach that during nerve stimulation (such as that applied by Rooney et al.), various side effects may occur. For instance, the stimulated nerve may be damaged over time due to a charge build-up from delivered electrical stimulation energy (col 3 line 59 - col 4 line 5). To alleviate this side effect, Libbus et al. apply a charge balanced biphasic waveform. This type of waveform prevents the build-up of charge left on the tissue that may cause damage, while also providing the intended therapeutic effect. Thus Libbus et al. teach and suggest that electrical stimulation therapy can be applied without causing damage to the nerve. Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the treatment system and method of Rooney et al. to apply the stimulation using charge-balanced biphasic waveforms since Libbus et al. explicitly teach that said waveforms prevent tissue damage commonly associated with electrical stimulation therapy that may create further conduction abnormalities.
In regard to claim 16, Rooney et al. teach that the monopolar single contact electrode comprises an anchoring element comprising a barb (para 160-162, includes barbs or tines).
In regard to claim 19, Rooney et al. teach a fixation mechanism to prevent the lead from migration, wherein during insertion the fixation mechanism may be in a collapsed state that when expelled from the insertion device expand to preventing withdrawal of lead from the tissue. This is considered to be suggestive of the anchoring element sized and configured so that, when in contact with the tissue, the anchoring element takes purchase in the tissue and resists dislodgement or migration out of the tissue. Moreover, Strother et al. including a anchoring mechanism for similar reasons, and explicitly teaches that the electrode is not deployed until after it has been correctly located during the implantation (installation) process (para 316, also para 314-318).
In regard to claim 20, Strother et al. teach that the single contact electrode comprises a surface area of 0.001-200 mm² (para 311, 10-20 mm² which anticipates the claimed range).
In regard to claim 25, Rooney et al. teach that the monopolar single contact electrode comprises an anchoring element sized and configured so that, when in contact with the tissue, the anchoring element takes purchase in the tissue and resists dislodgement or migration out of the tissue (para 160-162, includes barbs or tines).
In regard to claim 26, Rooney et al. teach the lead comprises one anchoring element located at a distal region of the lead (para 163).
In regard to claim 27, Rooney et al. teach the lead comprises more than one anchoring element located at a distal region of the lead (para 162).
In regard to claim 29, Rooney et al. disclose a method comprising:
inserting an electrode lead into a tissue until the electrode lead is in operative electrical position relative to a peripheral nerve innervating a painful region and wherein the electrode lead comprises an anchoring element (para 8 and 21, for treatment of pain with peripheral nerve stimulation, the electrodes are implanted in close proximity upstream from the source or pain; the proximal location of Rooney et al. comprising an “operative electrical position relative” to the nerve; para 160, teach use of fixation structures commonly used to prevent lead migration in the tissue);
applying electrical stimulation to the peripheral nerve through the electrode lead and an electrical stimulation device, wherein the electrical stimulation comprises an intensity (para 61-64, via the applied stimulation; para 7 and 71, stimulation for PNS is applied with a signal amplitude which is considered the same as the intensity);
activating the peripheral nerve through the application of the electrical stimulation to the peripheral nerve (para 62, stimulation from electrodes located upstream of the pain region provides paresthesia to the region where the patient perceives pain).
Rooney et al. does not teach using a single contact electrode placed in operative electrical position relative to a peripheral nerve. Strother et al. discloses implantable pulse generator systems and teaches that monopolar electrode configurations are known and are preferred in situations where the electrode may be located further from the target tissue region (para 309) which is beneficial since activation of the tissue is less sensitive to exact placement of the electrode. This is considered useful in Rooney et al. which places the electrode proximate or near the target peripheral nerve is a region upstream of the painful region so that the target nerve can achieve effective neural activation with a lower stimulation threshold. Therefore, it is considered to have been obvious to one of ordinary skill in the art to modify the peripheral nerve stimulation teaching of Rooney et al. to use a single contact or monopolar electrode since Strother et al. explicitly teach that monopolar electrodes offer the advantage that activation of the tissue is less sensitive to less exact electrode placement, thereby reducing the need for precise electrode placement which in turn would simplify implantation, improve procedural flexibility, reduce implant time, and lower energy use.
Neither Rooney et al. nor Strother et al. teach evoking muscle contraction within at least a portion of the targeted painful region nor for providing the stimulation without damaging the peripheral nerve.
Massengale teaches that in order to determine proximity of a stimulation device to a peripheral nerve, an electrical stimulation signal is transmitted to the target nerve to cause a contraction or twitch in the muscle innervated by that nerve (para 109). The magnitude of the twitch is dependent on the applied voltage and proximity of the stimulation tip to the nerve. Modification of Rooney et al. to apply the electrical stimulation to a peripheral nerve to evoke a twitch or contraction in the muscle is considered to have been obvious to one of ordinary skill in the art since Massengale explicitly teaches that motor responses are commonly used during implantation to verify appropriate electrode placement before chronic stimulation. The modification would comprise the application of a known technique of using a visible muscle twitch to aid in adjusting placement of a stimulation electrode.
Additionally, the technique described above allowing for the electrode to be placed away from the target nerve is considered to prevent damage to the nerve. However, no reference expressly teaches the limitation. Libbus et al. teach that during nerve stimulation (such as that applied by Rooney et al.), various side effects may occur. For instance, the stimulated nerve may be damaged over time due to a charge build-up from delivered electrical stimulation energy (col 3 line 59 - col 4 line 5). To alleviate this side effect, Libbus et al. apply a charge balanced biphasic waveform. This type of waveform prevents the build-up of charge left on the tissue that may cause damage, while also providing the intended therapeutic effect. Thus Libbus et al. teach and suggest that electrical stimulation therapy can be applied without causing damage to the nerve. Therefore, it is considered to have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the treatment system and method of Rooney et al. to apply the stimulation using charge-balanced biphasic waveforms since Libbus et al. explicitly teach that said waveforms prevent tissue damage commonly associated with electrical stimulation therapy that may create further conduction abnormalities.
In regard to claim 31, Rooney et al. teach that the electrical stimulation is delivered by an external pulse generator (para 54 and 170).
In regard to claim 32, Rooney et al. teach the lead comprises one anchoring element located at a distal region of the lead (para 163).
Claim 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rooney et al. (US Publication no. 2007/0150034) in view of Strother et al. (US Publication no. 2007/0060980), Massengale (US Publication no. 2008/0300530) and Libbus et al. (US Patent no. 8,103,341 – disclosed by Applicant), further in view of Bennett et al. (US Publication no. 2007/0239224).
In regard to claim 14, the cited prior art substantially suggests the invention as claimed, however does not teach that the electrode extends from a coiled lead, wherein the lead comprises one or more ink markings. Bennett et al. describes a lead for stimulating nerves and muscles. The lead is constructed of a coiled conductor (para 174) and including two ink markings 20 and 21 to aid the physician in the proper placement (para 190). It is therefore considered to have been obvious to modify the leads utilized by the prior art to be coiled and include ink markings since Bennett et al. explicitly teach the coiled lead construction, wherein the modification would include the substitution of a known element for another, and Bennett et al. explicitly teach that ink markings aid in proper lead placement.
Claim 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rooney et al. (US Publication no. 2007/0150034) in view of Strother et al. (US Publication no. 2007/0060980), Massengale (US Publication no. 2008/0300530) and Libbus et al. (US Patent no. 8,103,341 – disclosed by Applicant), further in view of Sethna et al. (US Patent no. 8,751,018).
In regard to claim 17, the cited prior art substantially suggests the invention as claimed, however does not teach that the anchoring element comprises a bend. Sethna et al. teaches an implantable medical lead which includes a lead bend that biases into its curved configuration to facilitate passive fixation of the lead 10 at the implantation site (col 18 lines 19-22). Therefore, it is considered to have been obvious to one of ordinary skill in the art to employ a bend as a fixation mechanism since it is explicitly taught by Sethna et al., wherein the modification would comprise the application of a known technique to a known device to yield a predictable result for passive fixation in the tissue.
Claim 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rooney et al. (US Publication no. 2007/0150034) in view of Strother et al. (US Publication no. 2007/0060980), Massengale (US Publication no. 2008/0300530), and Libbus et al. (US Patent no. 8,103,341 – disclosed by Applicant), further in view of Griffith et al. (US Patent no. 6,325,764).
In regard to claim 18, the cited prior art substantially suggests the invention as claimed, however does not teach the step of decreasing the intensity of the electrical stimulation as the single contact electrode is advanced closer to the peripheral nerve until a desired indicator response is reached. Massengale teaches that the magnitude of the muscle twitch or contraction depends on the voltage of the electrical pulse and also the proximity of the tip to the nerve. Therefore, if a constant voltage is applied, the user of the device described herein can detect the distance of the tip to the target nerve by the magnitude of the muscle contractions that result from the electrical pulse (para 109). However, does not teach decreasing the intensity until the desired indicator response is reached. Griffith et al. teach a method to facilitate nerve location for peripheral nerve procedures. Like Massengale, Griffith et al. teach that twitches generated in response applied charge indicate proximity to the nerve. Twitches generated from high charge quickly reach a peak which become indistinguishable as the target nerve is reached. The high charge is beneficial when further away from the nerve. A low charge must then be applied so that the twitches gradually increase in magnitude and intensity are more beneficial on closer approach to the nerve (col 3 lines 53 – col 4 line 27). Griffith et al. further teach that as the target nerve is approaches, the intensity of locating pulses is lowered for the reasons described above an is applied until a desired indicator response of 2 twitches per second is observed thereby indicating that the target nerve has been adequately located (col 14 lines 12-43). Therefore, it is considered to have been obvious to one of ordinary skill in the art to employ the nerve locating technique of Griffith et al. during the electrode placement of Rooney et al. as modified by Massengale because progressively reducing the stimulation intensity while advancing the electrode toward the peripheral nerve allows the practitioner to better observe twitch responses indicating nerve location thereby improving placement accuracy.
Claims 24 and 28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rooney et al. (US Publication no. 2007/0150034) in view of Strother et al. (US Publication no. 2007/0060980), Massengale (US Publication no. 2008/0300530) and Libbus et al. (US Patent no. 8,103,341 – disclosed by Applicant), further in view of Mann et al. (US Publication no. 2007/0112404).
In regard to claims 24 and 28, the cited prior art substantially suggests the invention as claimed, however does not teach that the electrical stimulation device is integrated with the single contact electrode. Mann et al. describe a microstimulator 100 comprising one or more electrodes 142 (para 2, 39 and 44-45). The microstimulator 100 of Mann et al. is a device that integrates electrodes with the stimulation device. Additionally, the microstimulator 100 may be operated in monopolar fashion (para 45). It is considered to have been obvious to one of ordinary skill in the art to modify the stimulation devices described by the cited prior art above to be integrated with the electrodes since Mann et al. show the configuration in this manner is suitable to be implanted proximate to the target tissue so that the stimulation current produced by the electrodes stimulates the target tissue to reduce symptoms or otherwise provide therapy for a wide variety of conditions and disorders. The modification is considered to comprise the application of a known technique to a known device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gliner et al. (US Patent no. 7,945,330) provides a technique for optimizing stimulation parameters for peripheral nerve stimulation.
Zweber et al. (US Publication no. 2008/0147158) discloses an implantable coiled lead suitable for peripheral nerve stimulation.
Erickson et al. (US Patent no. 7,359,751) describes a trial stimulator.
Whitehurst et al. (US Publication no. 2005/0143789) is directed to methods and systems of stimulating peripheral nerves to treat pain.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 6 August 2026
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